Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
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- STATUS
- Recruiting
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- End date
- Jun 24, 2023
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- participants needed
- 10560
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- sponsor
- AnchorDx Medical Co., Ltd.
Summary
AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.
Description
This is a prospective, multi-center, observational cohort study and seeks to enroll 10,560 participants with pulmonary nodules smaller than 3 cm in diameter from 21 hospitals in China. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years ( baseline, 3 months, 6 months, 12 months, 24 months and 36 months). Their blood samples, CT or LDCT scans data, and clinical data will be collected at each visit and Formalin-fixed paraffin-embedded (FFPE) tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.
Details
| Condition | Pulmonary Nodules |
|---|---|
| Treatment | ctDNA methylation analysis by NGS |
| Clinical Study Identifier | NCT03651986 |
| Sponsor | AnchorDx Medical Co., Ltd. |
| Last Modified on | 21 February 2022 |
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